BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 8555821 · Received April 26, 2019

    Report

    Report Number
    1818910-2019-91762
    Event Type
    Injury
    Date Received
    April 26, 2019
    Date of Event
    May 31, 2013
    Report Date
    April 8, 2019
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWY
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA-(B)(4). ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT PRODUCT CODE WAS SOLD INTERNATIONALLY. IT WAS SOLD IN THE US UNDER A DIFFERENT PRODUCT CODE. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. OCCUPATION IS A NON-HEALTHCARE PROFESSIONAL. (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES INJURY, EXPOSURE TO ELEVATED LEVELS OF METAL TOXIN, PAIN, AND SUFFERING WHICH HAS GREATLY IMPACTED THE PATIENT'S QUALITY OF LIFE. DOI: (B)(6) 2005; DOR: (B)(6) 2013; UNKNOWN HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351313 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD KWY DEPUY INTERNATIONAL LTD - 8010379 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention